AHEALON®

AHEALON®

Drug Labeling and Warnings

Drug Details

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AHEALON - arnica montana, calendula officinalis flowering top, echinacea angustifolia, st. johns wort, silver, sulfur, allylthiourea and urtica urens spray 
PRINCETON BIOTECHNOLOGY CORPORATION

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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AHEALON®

CAUTION:

Federal law prohibits dispensing without a prescription.

DESCRIPTION:

AHEALON® is a US Patent Pending biochemical homeopathic medication indicated for the treatment of pain and or inflammation, as well as a general healing aid, an infection deterrent, an agent to help reduce scar tissue and a source of moisturization (dry/cracked/burned skin); treatment can include: burn injuries, radiation dermatitis, arthritis (including osteoarthritis, rheumatoid arthritis, and psoriatic arthritis), rashes, wounds (chronic/acute), pressure sores, neuropathic discomfort and any generally inflamed area. The active ingredients in AHEALON consist of the following: Arnica 10C/30C/50M, Calendula 10C/30C/50M, Echinacea ANG 10C/30C/50M, Hypericum 10C/30C/50M, Silver 10C/30C/50M, Sulfur 10C/30C/50M, Thiosinaminum 10C/30C/50M, Urtica 10C/30C/50M. These drug ingredients are listed in the Homoeopathic Pharmacopoeia of the United States (HPUS).[1]

Inactive ingredients: Sea Minerals, Silver, Water.

Pharmacological Class: Homeopathic drug.

Dosage form: Liquid; may be used topically at 0.15 ML per spray application. Liquid; may be used as a gauze saturant. Liquid; may be aerosolized for bronchial/sinus use.

CLINICAL PHARMACOLOGY:

The active ingredients in AHEALON are simple biochemical compounds. The exact mechanism of action is unknown, however it is believed that AHEALON helps to stimulate healing response mechanisms.

ARNICA has been used for medicinal purposes since the 1500s. In general the constituent base is complex, consisting of a wide variety of chemicals of variable effect and potency; for example, one such complex can contain derivatives of thymol[2] also known as 2-isopropyl-5-methylphenol, a naturally occurring biocide with strong antimicrobial/anti-fungal attributes[3] that can reduce bacterial resistance to common drugs such as penicillin.[4] Numerous studies have demonstrated its antimicrobial (including Aeromoans hydrophila and Staphylococcus aureus)[5] effects, ranging from inducing antibiotic susceptibility in drug-resistant pathogens to powerful antioxidant properties,[6] and to reduce bacterial resistance to antibiotics through a synergistic effect;[7] it has also been shown to be effective particularly against Fluconazole-resistant strains, and there is evidence of anti-tumor properties.[8] Today Arnica is generally used to reduce inflammation, and to heal wounds. It is also commonly used for injuries such as sprains and bruises.[9] Some surgeons recommend Arnica to speed recovery from soreness and bruising associated with surgery.

CALENDULA plant pharmacological studies have suggested that Calendula extracts may have anti-viral, antigenotoxic, cytotoxic anti-tumor, anti-inflammatory and lymphocyte activation properties.[10] Users in trials also experienced less radiation induced pain and fewer breaks in treatment. [11]

ECHINACEA ANG There have been no case reports of any drug interactions with Echinacea and "the currently available evidence suggests that echinacea is unlikely to pose serious health threats for patients combining it with conventional drugs."[12] Archaeologists have found evidence that Native Americans may have used Echinacea for more than 400 years to treat infection and wounds. Today uses include a method to shorten the duration of the common cold and flu and reduce symptoms, such as sore throat/pharyngitis, cough, and fever. Several laboratory and animal studies suggest that it contains active substances that enhance the activity of the immune system, relieve pain, reduce inflammation, and have hormonal, antiviral, and antioxidant effects. Often recommended to treat urinary tract infections, vaginal yeast (Candida) infections, ear infections, athlete's foot, sinusitis, hay fever/allergic rhinitis, as well as slow-healing wounds. [13] The constituent base for echinacea is complex, consisting of a wide variety of chemicals of variable effect and potency. Some chemicals may be directly antimicrobial, while others may work at stimulating or modulating different parts of the immune system. Chemical constituents include phenols (cichoric acid and caftaric acid); others that may have important health effects include alkylamides and polysaccharides. The immunomodulatory effects of echinacea preparations are likely caused by fat-soluble alkylamides (alkamides).[14] Alkylamides bind particularly to human CB2 and to a much lesser degree to CB1 receptors; as a result they are implicated in a variety of modulatory functions, including immune suppression, induction of apoptosis, cell migration and inhibition of tumor necrosis factor α TNF-alpha.[15] Although the triggering factors for many autoimmune diseases are not known, one of the key inflammatory mediators in the attending chronic inflammatory process is the cytokine, tumor necrosis factor-alpha (TNF-α). TNF-α overexpression acts as a driver for inflammation that damages cartilage, bone and bowel mucosa, and TNF-α inhibition leads to significant clinical improvements and reduction of this damage. [16]

HYPERICUM has a history of being used as a medicine dating back to ancient Greece with antibacterial and antiviral properties. Its anti-inflammatory properties are useful when applied to the skin to help heal not only wounds and burns, but also eczema and hemorrhoids. In recent years it has been studied extensively as a treatment for depression. A number of studies show that it may help treat mild-to-moderate depression. An early study suggests that it may also help relieve physical and emotional symptoms of Premenstrual syndrome/PMS in some women, including cramps, irritability, food cravings, and breast tenderness. It may also help to improve mood and anxiety during menopause. [17]

THIOSINAMINUM is a trituration of the crystals of allyl sulphocarbamide. Uses include resorb/dissolve/reduction of scar tissue/fibrosis, tumors, strictures, plantar fasciitis, immune system diseases, enlarged glands, eye concerns, scleroderma, tinnitus aurium, amenorrhea, cystic fibrosis, polycystic ovaries, fibroids and pelvic adhesions.[18]

SILVER has a proven record of broad-spectrum antimicrobial activity that includes antibiotic-resistant bacteria, with minimal toxicity toward mammalian cells at low concentrations, and has a less likely tendency than antibiotics to induce resistance due to its activity at multiple bacterial target sites. [19] [20] [21] [22] [23] Silver combined with sulfur is used to topically treat infections of second- and third-degree burns. Wound dressings that contain silver are increasing in importance due to the recent increase of antibiotic-resistant bacteria, such as MRSA.[19]

SULFUR has been in therapeutic use for over 2,000 years, especially for its antiseptic attributes; also helps to control itching/irritation. Sulfur combined with silver is used to topically treat infections of second- and third-degree burns; it also kills a wide variety of bacteria. Also used in the treatment of skin disorders and irritations, such as eczema, dandruff, folliculitis, warts, pityriasis versicolor, psoriasis and acne. It has natural antiseptic properties and plays an essential role in the synthesis of collagen.[24] [25] Well designed studies, most conducted in Israel, suggest that balneotherapy/sulfur can help treat several different kinds of arthritis. People who took sulfur baths and other spa therapies improved strength, had less morning stiffness, had better walking ability, and less inflammation, swelling, and pain in joints, particularly in the neck and back. [26]

URTICA has been used for hundreds of years to treat painful muscles and joints, eczema, arthritis and gout. Today it is also used to treat urinary problems during the early stages of benign prostatic hyperplasia, for urinary tract infections, for hay fever/allergic rhinitis (reduced sneezing and itching), or for treating joint pain, sprains and strains, tendonitis, and insect bites. [27] [28] [29] [30]

CLINICAL STUDIES:

A variety of controlled clinical studies have been favorably performed using one or more of the ingredients herein, but no study has been completed with the combination of all of the AHEALON ingredients.

INDICATIONS:

AHEALON is indicated for the acute and chronic treatment of pain and or inflammation, as well as a general healing aid, an infection deterrent, an agent to help reduce scar tissue and a source of moisturization (dry/cracked/burned skin), that include: all burn injuries, radiation dermatitis, surgical incisions, rashes, pruritic conditions, arthritis/joint pain, lower back pain, wounds, pressure sores, tumors, neuropathic discomfort and any generally painful and or inflamed area. Pain remediation can secondarily benefit sleep quality and duration; pain reduction can also relieve chronic stress induced Cortisol production and thus contribute to less patient stress and anxiety and the reversal of chronic non-healing wounds. Expedited use on pain/trauma patients may quickly control pain such as to reduce the possibility of shock.

CONTRAINDICATIONS:

Although there are no known contraindications, patients who are allergic to any AHEALON ingredient should consult a physician prior to taking the medication. (Refer to Section on Hypersensitivity)

WARNINGS:

Choking Hazard; small parts. Keep out of reach of children.

PRECAUTIONS:

Topical application of AHEALON may cause initial stinging, with progressive desensitization as treatment progresses. Carefully adjust AHEALON dosage to those who might be hypersensitive to any of the ingredients of this drug.

Hypersensitivity: Caution should be used when administering to patients with a history of contact sensitivity to sulfur or silver or to the other ingredients that comprise this drug.

Information for patients: Patients using AHEALON should receive the following information and instructions:

  1. AHEALON is to be used throughout the healing process only as directed by your physician.

  2. It is important to systematically follow physician advised application times; do not skip AHEALON applications and/or double applications.

Drug Interactions: There are no known AHEALON drug interactions.

Carcinogenesis, mutagenesis, and impairment of fertility: No studies have been done on the carcinogenesis, mutagenesis, or impairment of fertility of AHEALON. In general, at the dilutions herein formulated, homeopathic drugs are not known to cause direct or indirect harm to a fetus. AHEALON should be given to a pregnant woman only if clearly needed.

Effects of each ingredient is not listed as a carcinogen by ACGIH, IARC, NIOSH, NTP, or OSHA; each is a GRAS substance: generally recognized as safe.

Pregnancy Category C. Animal reproduction studies have not been conducted with AHEALON. Pregnant women are given AHEALON only if clearly needed.

Nursing mothers: It is not known whether this drug is secreted in human milk. However, since many drugs are secreted in human milk, caution should be exercised when AHEALON is administered to a nursing woman.

Pediatric use: Carefully adjust AHEALON dosage when treating young children who might have a hypersensitivity to any of the ingredients of this drug.

ADVERSE REACTIONS:

AHEALON contains low doses of active ingredients. Therefore there are minimal known side effects. (see PRECAUTIONS for hypersensitivity information)

OVERDOSAGE:

Due to the low concentrations of active AHEALON ingredients, adverse reactions following overdosage are extremely rare. Care must be taken not to exceed the recommended AHEALON dosage.

DOSAGE AND ADMINISTRATION:

For topical administration (each spray contains approximately 0.15 ML AHEALON) spray 4 to 6 times, 3 to 5 inches away from: all burns, wounds, pressure sores, debrided areas, arthritis, incisions, rashes, scar tissue, painful, bruised and inflamed areas. Use adjunctively with standard measures of care. For intense pain apply every 3 minutes, as pain subsides every 5 minutes, then every 10 minutes, adjusted for each patient, up to hourly. Pain should take longer to return after each application. Generally effective in 12 seconds to 12 minutes; results can last ¼ - 8 hrs. Apply before, during and after debridement; treatment may enhance autolytic debridement. For chronic pain/sores, spray AHEALON as directed, such as every hour, for 2 - 6+ weeks. For maximum absorption, spray should be applied to clean skin/tissue at the beginning of the day and throughout the day per physician directed regimen throughout the healing process – it is important not to miss an application. For burn wounds/grafts, apply to ensure that wounds are kept in a moist condition. AHEALON can be used as a gauze saturant for burns/wounds. Generally use more at first, then use less later. Acting to stop pain/reduce inflammation allows for more tissue perfusion, which allows tissues to acquire more Oxygen and nutrients as vital growth factors for expedited wound closure and healing/infection resistance. Moisturization also helps to ensure a supple wound. AHEALON application to nerve trunk areas, such as neck, could augment  effectiveness. Concomitant use with opioid drugs may produce the same analgesic effects with less opioid use. Expedited topical use for trauma/pain patient could act to quickly stop/reduce pain and thus act to reduce the possibility of shock.

Maintenance phase: In order to maintain symptomatic relief, AHEALON should be continued at a physician advised dose level. It is important to use systematically as per physician determined regimen of times and dosage levels throughout the healing period. Treatment duration depends on each individual.

INACTIVE INGREDIENTS:

Sea Minerals, Silver, Water.

HOW SUPPLIED:

Liquid in a 2 ounce/60 ML finger-pump spray bottle made from Cobalt Blue PET for safety; sprayer has a protective over-cap; each bottle contains approximately 400 spray applications at 0.15 ML/spray.
NDC: 52793-700-02

REFERENCES:

  1. The Homeopathic Pharmacopoeia of the United States (HPUS), December 2000 edition, Falls Church, Virginia.

  2. Weremczuk-Jezyna I, Kisiel W, Wysokińska H (2006). "Thymol derivatives from hairy roots of Arnica montana". Plant Cell Rep. 25 (9): 993–6. doi:10.1007/s00299-006-0157-y. PMID 16586074.

  3. Ahmad A, et al, Proton translocating ATPase mediated fungicidal activity of eugenol and thymol,Fitoterapia (2010), doi:10.1016/j.fitote.2010.07.020

  4. Palaniappan, K. and Holley, R.A. Use of natural antimicrobials to increase antibiotic susceptibility of drug resistant bacteria doi:10.1016/j.ijfoodmicro.2010.04.001.

  5. Dorman, H.J.D.; Deans, S.G. Antimicrobial agents from plants: antibacterial activity of plant volatile oils. J. Appl. Microbiol. 2000, 88, 308-316.

  6. Ű. Űndeğer a, A. Basaran b, G.H. Degen c, N. Basaran a Antioxidant activities of major thyme ingredients and lack of (oxidative)DNA damage in V79 Chinese hamster lung fibroblast cells at low levels of carvacrol and thymol doi:10.1016/j.fct.2009.05.020

  7. Palaniappan, K. and Holley, R.A. Use of natural antimicrobials to increase antibiotic susceptibility of drug resistant bacteria doi:10.1016/j.ijfoodmicro.2010.04.001.

  8. The Rural School and Hookworm Disease. Jno A Ferrell, 1914 http://books.google.com/books?id=omYAAAAAYAAJ&dq=THE+RURAL+SCHOOL+AND+hookworm+disease&printsec=frontcover&source=bl&ots=MzB2Qc83MN&sig=XuzEewv27ty90cJ3IxS8fhyh0A4&hl=en&ei=KHKUSsOVKY_QsQOmnNnZBg &sa=X&oi=book_result&ct=result&resnum=1#v=onepage&q=&f=true

  9. http://www.umm.edu/altmed/articles/arnica-000222.htm#ixzz1qSojMAmu

  10. Jimenez-Medina E, Garcia-Lora A, Paco L et al. (2006). A new extract of the plant Calendula officinalis produces a dual in vitro effect: cytotoxic anti-tumor activity and lymphocyte activation. BMC Cancer. 6:6.

  11. Pommier P.et al. J Clinical Oncol 2004; 22:447-1453

  12. Izzo AA, Ernst E (2009). "Interactions between herbal medicines and prescribed drugs: an updated systematic review". Drugs 69 (13): 1777–98. doi:10.2165/11317010-000000000-00000. PMID 19719333.

  13. http://www.umm.edu/altmed/articles/echinacea-000239.htm#ixzz1qSy3taCX

  14. Wichtl Max (Ed.) 2004. Herbal Drugs and Phytopharmaceuticals. medpharm Scientific Publishers/CRC Press. pp 179–186. ISBN 0-8493-1961-7

  15. Gertsch Jürg et al. (2004). “Alkylamides from Echinacea are a New Class of Cannabinomimetics”. J. Biol. Chem. 281 (20), pp. 14192–14206. http://www.jbc.org/content/281/20/14192.full.pdf

  16. Peter T Nash, MB BS, FRACP, Director, Rheumatology Research Unit, Nambour Hospital, Sunshine Coast1, Timothy H J Florin, MB BS, FRACP, Director of Gastroenterology; and Associate Professor of Medicine, University of Queensland

  17. http://www.umm.edu/altmed/articles/st-johns-000276.htm#ixzz1qT3EkJ8B

  18. http://www.fertilityproregistry.com/article/remedies-for-obstruction-of-the-epididymis-thiosinaminum-6c.html#ixzz1qYf7JalC

  19. Chopra I (April 2007). "The increasing use of silver-based products as antimicrobial agents: a useful development or a cause for concern?". The Journal of Antimicrobial Chemotherapy 59 (4): 587–90. doi:10.1093/jac/dkm006. PMID 17307768.

  20. Tian J, Wong KK, Ho CM et al (January 2007). "Topical delivery of silver nanoparticles promotes wound healing". Chemmedchem

    2 (1): 129–36. doi:10.1002/cmdc.200600171. PMID 17075952.
  21. Several Silver-Containing Wound Dressings: Abstract and Introduction Medscape.com. 2006-03-23. Retrieved 2010-07-10.

  22. Comparison of Two Silver Dressings for Wound Management in Pediatric Burns | WOUNDS". Woundsresearch.com. Retrieved 2010-07-10.

  23. Silver Antimicrobial Dressings in Wound Management: A Comparison of Antibacterial, Physical, and Chemical Characteristics ConvaTec Ltd, Flintshire, UK

  24. Medical Uses of Sulfur | eHow.com http://www.ehow.com/info_8680883_medicaluses-sulfur.html#ixzz1qr0aX1qZ

  25. http://www.umm.edu/altmed/articles/sulfur-000328.htm#ixzz1qr306aDH

  26. http://www.umm.edu/altmed/articles/sulfur-000328.htm#ixzz1qr49WWIc

  27. Chrubasik JE, Roufogalis BD, Wagner H, Chrubasik S. A comprehensive review on the stinging nettle effect and efficacy profiles. Part II: urticae radix. Phytomedicine. 2007;14(7-8):568-79.

  28. Ernst E, Chrubasik S. Phyto-anti-inflammatories. A systematic review of randomized, placebo-controlled, double-blind trials. Rheum Dis Clin North Am. 2000;26(1):13-27.

  29. Helms S, Miller A. Natural treatment of chronic rhinosinusitis. Altern Med Rev. 2006 Sept;11(3):196-207.

  30. http://www.umm.edu/altmed/articles/stinging-nettle-000275.htm#ixzz1qYJeFKiG

Princeton BIOTECHNOLOGY
Innovations for Health and Healing™

Princeton Biotechnology Corporation, Barrington, NJ 08007 USA
www.ahealon.com 800-250-9006

Revised November 2012

PACKAGE LABEL

PRESCRIPTION ONLY MEDICINE

STOPS PAIN
in 12 sec – 12 min

Ahealon®
6-in-1 TOPICAL SPRAY
for pain, burns, inflammation, wounds, arthritis, incisions

Stops Pain
Moisturizes
Aids Healing
Fights Infection
Reduces Scar Tissue
Reduces Inflammation

use often throughout the healing process

2 oz / 60 ml

Distributed By:
Princeton Biotechnology Corporation
FDA NDC: 52793-700-02

Stops Pain 12 sec – 12 min
Burns, Wounds, Arthritis
Ahealon
®

Directions: Spray 4 to 6 times, 3 to 5 inches away from: all burns, wounds, pressure sores, arthritis, incisions, painful and inflamed areas.

Reapply as needed for pain. Pain takes longer to return after an application. Use adjunctively with standard measures of care.

Generally Effective in 12 sec to 12 min; can last ¼ - 8 hrs. For chronic pain spray as your doctor directs for 2 - 6+ weeks.

Helps: stop pain, reduce inflammation (allows more tissue perfusion = more Oxygen and nutrients as vital growth factors for wound closure and healing/infection resistance), fight infection, stop scar tissue; also for moisturization.

Important to Spray Often: such as every ½ hr; as healing progresses ≥ 8 times per day throughout the healing process.

All Rights Reserved, 2012©Princeton Biotechnology Corporation

Safety: Nontoxic, opiate free, non-addictive, may sting initially, scent free, eye safe, steroid free, non-staining, non-greasy, taste free, hypoallergenic (see insert).

Warning: Choking Hazard-Small Parts (spray is child safe)

Keep out of reach of children.

If pregnant or nursing ask your health professional before use.

Active Ingredients: HPUS: Arnica 10C/30C/50M, Calendula 10C/30C/50M, Echinacea ANG 10C/30C/50M, Hypericum 10C/30C/50M, Silver 10C/30C/50M, Sulfur 10C/30C/50M, Thiosinaminum 10C/30C/50M, Urtica 10C/30C/50M.

Other Ingredients: Water, Sea Minerals, Silver.

Made in USA

U. S. Patent Pending

Manufactured for:
Princeton Biotechnology Corporation,
Barrington, NJ 08007 USA
800-250-9006 Ahealon.com

Princeton BIOTECHNOLOGY™
Innovations for Health and Healing™

Ahealon Label
AHEALON  
arnica montana, calendula officinalis flowering top, echinacea angustifolia, st. johns wort, silver, sulfur, allylthiourea and urtica urens spray
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 52793-700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana30 {kp_C}  in 60 mL
Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ) Calendula Officinalis Flowering Top30 {kp_C}  in 60 mL
Echinacea Angustifolia (UNII: VB06AV5US8) (Echinacea Angustifolia - UNII:VB06AV5US8) Echinacea Angustifolia30 {kp_C}  in 60 mL
St. John's Wort (UNII: UFH8805FKA) (St. John's Wort - UNII:UFH8805FKA) St. John's Wort30 {kp_C}  in 60 mL
Silver (UNII: 3M4G523W1G) (Silver - UNII:3M4G523W1G) Silver30 {kp_C}  in 60 mL
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur30 {kp_C}  in 60 mL
Allylthiourea (UNII: 706IDJ14B7) (Allylthiourea - UNII:706IDJ14B7) Allylthiourea30 {kp_C}  in 60 mL
Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9) Urtica Urens30 {kp_C}  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52793-700-021 in 1 CARTON
160 mL in 1 BOTTLE, SPRAY
2NDC: 52793-700-061 in 1 CARTON
26 mL in 1 BOTTLE, SPRAY
3NDC: 52793-700-101 in 1 CARTON
310 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/09/2012
Labeler - PRINCETON BIOTECHNOLOGY CORPORATION (964830348)
Establishment
NameAddressID/FEIBusiness Operations
Washington Homeopathic Products084929389MANUFACTURE(52793-700)

Revised: 12/2012
 
PRINCETON BIOTECHNOLOGY CORPORATION


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